1. Field of the Invention
The present invention relates to a method for making customized ostomy devices of the type including a waste collection pouch adapted to be adhesively affixed to the skin surrounding the stoma and more particularly to cutting guides for ostomy devices customized to the stomal periphery of the user and a method for fabricating such cutting guides.
2. Description of the Related Art
In connection with surgery for a number of diseases in the gastro-intestinal tract a consequence is, in many cases, that the colon, the ileum or the urethra has been exposed surgically and the patient is left with an abdominal stoma and the effluents or waste products of the body, which are conveyed through these organs, are discharged through the artificial orifice or opening and are collected in a collection bag, which is usually adhered to the skin by means of an adhesive wafer or plate having an inlet opening for accommodating the stoma. Also in connection with a fistula, the patient will have to rely on an appliance to collect the bodily material emerging from such opening.
Ostomy appliances are well known. Such appliances may be two-piece or one-piece appliances. In both types of appliances, a body side member is attached to the wearer""s abdomen, and optionally a receiving member or bag is attached to the body side ostomy member for receiving exudates from the ostomy in case of a two-piece appliance. The body side member comprises an adhesive wafer for securing the device to the wearer""s abdomen, said wafer having a hole for accommodating the ostomy and conveying the material discharged through the artificial orifice or opening into the collection bag.
Wafers and ostomy devices are manufactured in a variety of different standard shapes, sizes and configurations to meet the many different needs of the users. Although these standard products meet the needs of the average user, they do not ideally meet the needs of any particular individual. In most cases, the user must adapt the product prior to use to suit his or her anatomy or lifestyle. Typical modifications which can be performed include cutting of the stoma receiving opening in the wafer, trimming the outside of the wafer, addition of convex inserts, application of paste and filters and folding or trimming the pouch. A conventional cutting guide is representatively depicted in FIG. 1.
However, even these modifications may not result in an ideal product for the particular individual. Users may have difficulty in performing the modifications, as well. This may be due to poor dexterity, poor eyesight or diminished mental capacity. Some desired modifications may be very difficult or impossible without special equipment. Some users may see making such modifications as taking too much time or for other reasons to be an undesirable task.
Thus, because of difficulties or simple reluctance on the part of the user, the modifications to the products are done poorly and as a result, product performance may suffer.
European patent publication No. EP 800 804 discloses the fabrication of customized ostomy devices according to which the ostomy devices are produced having attributes selected according to measurement information obtained from the respective patent.
This solution, however, involves substantial logistic problems with respect to producing, storing and distributing the customized products.
It is the general object of this invention to eliminate the above problems by fabricating ostomy devices which are customized so as to be uniquely suited to the needs and preferences of each individual user. This object may be achieved in a variety of different ways, using technologies of different sophistication and cost.
The present invention relates to a customized label having an adhesive backing for adhering to a release liner of an ostomy appliance having an adhesive wafer with a hole therein for adhering to the stomal area of a patient. The label includes a customized pattern defining a cutting line corresponding to the stomal area of the patient for adapting the opening to the patient""s stoma. The pattern for the cutting line is obtained by measuring an outer contour of the stoma of the patient, and electronically recording the information relating to the stoma measurements for printing the customized pattern on the label having the adhesive backing in order to adapt the appliance to the patient.
According to a further embodiment, the present invention is directed to a customized ostomy appliance comprising an adhesive wafer for adhering to the stomal area of a specific patient having a stoma, the wafer having an opening for accommodating the stoma; an ostomy collection bag; a customized printed pattern indicating a cutting line for adapting the opening of the wafer to the specific patient; and a release liner having the printed pattern visible thereon for adapting the opening to the specific patient. The cutting line is obtained by measuring an outer contour of the stoma of the patient, and using the information relating to the measurements of the stoma to print the customized printed pattern for adapting the appliance to the specific patient.
The customized printed pattern may be printed on the release liner which is then placed on the adhesive wafer, or the pattern may be printed on a material having an adhesive backing for placing on the release liner.
The present invention further includes a method for customizing a standard ostomy appliance having an adhesive wafer with a hole therein for a patient having a stoma. The method includes the steps of measuring an outer contour of the stoma of the patient, recording information relating to the measurements of the stoma in electronic form, utilizing the electronic measurement information to select physical attributes of the stoma to be transferred to the ostomy appliance, and printing a customized cutting guide pattern for the hole corresponding with the selected physical attributes on a material for adhering to the wafer.
The pattern may be printed on a release liner, with the method further including the steps of placing the release liner on the wafer, and cutting the hole according to the printed pattern. Alternatively, the pattern may be printed on a label having an adhesive backing, and the method may further include the steps of placing the label on a release liner, placing the release liner on the wafer, and cutting the hole according to the pattern.